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Senior Manager, Computer System Validation

Location

Durham, NC, USA

Department

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At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, STD, LTD, generous vacation in your first year, sick time, and retirement savings!

Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

The Sr. Manager for Computer Systems Validation will lead the organizations validation department. This role will manage a group of internal CSV personnel and external consultants to implement compliant, validated information systems. This role will work with highly complex lab/manufacturing systems and ensure they are implemented according to regulatory requirements and maintain compliance throughout the system lifecycle. You will work in a global organization and interact with personnel from several different locations and departments and be responsible for growing and curating an industry leading computer validation team.

Responsibilities

  • Lead CSV activities in a multi-location organization with geographically separated CSV group.
  • Build and maintain a CSV program that involves management of personnel, resources, and multiple simultaneously running projects
  • Manage internal/external CSV personnel to facilitate completion of systems validation activities
  • Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology
  • Perform project management activities for CSV process within the scope of an overall project portfolio
  • Represent CSV during audits of internal computer systems validation activities, protocol/procedures, and prepare responses
  • Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents
  • Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems
  • Develop CSV policies and processes/procedures and continually improve upon them

Qualifications

  • BS degree in Computer Science, Life Science, or Engineering; Master’s degree preferred
  • 5-10 years of CSV experience in FDA regulated industry
  • Experience in the review, evaluation and testing of systems to ensure compliance with the FDA Electronic Records/Electronic Signatures regulation and 21 CFR Part 11
  • In-depth understanding of 21 CFR Part 11 and CSV processes
  • Strong people management skills
  • Excellent project management skills
  • Strong overall knowledge with IT infrastructure and applications
  • Able to work in a global and matrix environment
  • Excellent verbal and written communication skills
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

 

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 

 

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